Breath Analysis in Patients With Suspected Sarcoidosis: The VOCs-IS Study

Summary

Sarcoidosis is a chronic condition which predominantly affects the lungs and lymph glands within the chest, however, may affect any organ within the body. At the present time, very little is known as to the exact cause of sarcoidosis and it is widely believed that the condition arises due to overreaction of the immune system to an unknown trigger in the environment such as an infection. Alongside this, the clinical course and progression of the condition varies considerably; some patients have a very mild form which does require any specific treatment, where as other patients develop a more severe form which can lead to permanent scarring (fibrosis) of the lungs if left untreated. At the present time it is difficult to predict how a patient will be affected by their sarcoidosis as there is a distinct lack of clinically useful markers which help predict prognosis and identify people at risk of disease progression or those who require treatment.

The main aims of this study are to use a technique which captures and analyses breath samples to provide a profile of the chemicals known as volatile organic compounds (VOCs) which are present in the exhaled breath of patients with sarcoidosis. Specifically the study would look to see if these VOCs are different in patients with sarcoidosis compared to people who do not have sarcoidosis or any lung conditions. In addition, the study would look to see how these breath profiles relate to potential infections, change over time or in response to treatment with steroids.

The study will involve a total of 80 patients presenting with suspected sarcoidosis and involve a total of four study visits over the course of twelve months. During each study visit a sample of breath will be collected alongside a blood test to look for markers of disease activity as well as completion of two questionnaires relating to a patients degree of breathlessness and quality of life. At the start of the study an additional questionnaire will be completed to identify possible risk factors for the development of sarcoidosis as well as the option of providing a sample of blood for genetic testing (which is voluntary). In patients undergoing a bronchoscopy or endobronchial ultrasound (EBUS), a sample of fluid which naturally lines the airways (bronchoalveolar lavage) will also be taken and used for metagenomic sequencing to try and identify any microbes which might be present within the lung and airways.

Conditions

• Pulmonary Sarcoidosis

Interventions

OTHER

Breath Analysis

Breath analysis using the ReCIVA device will take place during each study visit.

OTHER

Pulmonary Function Tests

Full Pulmonary Function Tests will be performed at baseline and during each study visit if not performed as part of routine clinical care.

OTHER

Blood sampling and storage for genetic analysis

Additional voluntary consent will be sought for blood sampling and storage for genetic analysis at baseline.

OTHER

Blood sampling and storage of plasma for metabolomic analysis

Blood sampling and storage of plasma for metabolomic analysis will take place during each study visit.

OTHER

Bronchoalveolar lavage

Bronchoalveolar lavage will be performed at baseline on all participants undergoing investigation with bronchoscopy or EBUS as part of routine clinical care for investigation of suspected sarcoidosis.

OTHER

Sputum Culture

Sputum will be collected during each study visit if the patient can spontaneously expectorate and will be sent for routine microbial analysis as well as metagenomic sequencing.

OTHER

Spirometry

Spirometry will be performed on all healthy controls prior to enrolment into the study

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Stephen Fowler, MD FRCP · The University of Manchester

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2021-03-31

Completion

2021-10-08

Countries

• United Kingdom

Study Locations